February 2013 DMID Council-Approved Concepts
Concepts represent early planning stages for program announcements, request for applications, or solicitations for Council's input. If NIAID publishes an initiative from one of these concepts, we link to it below. To find initiatives, go to the Opportunities and Announcements portal.
NB: Council approval does not guarantee that a concept will become an initiative.
Table of Contents
Statistical and Data Coordinating Center for Clinical Research in Infectious Diseases
Request for Proposals
Contact: Frank Vidergar
Objective: To provide comprehensive statistical, data management, and analysis support activities for DMID-sponsored clinical research studies and trials.
Description: This initiative will support a Statistical and Data Coordinating Center for Clinical Research in Infectious Diseases to provide comprehensive and consistent statistical and data management support for DMID clinical research studies and trials spanning a wide range of infectious diseases and candidate products, including vaccines, diagnostics, devices, and therapeutics. These services are provided at multiple domestic and international sites.
Specifically, the program will provide a comprehensive array of statistical and data management support services, including:
- Web-based data collection, management, and quality control.
- Statistical consultation, design, and analysis.
- Assistance in developing study materials with related Web-based reports and training.
- Site management assistance.
- Electronic specimen tracking.
- Data reports to support safety/regulatory requirements.
DMID Regulatory Affairs Support
Request for Proposals
Contact: Tiffany Chadwick
Objective: To provide scientific, regulatory, technical, project management, and administrative assistance for a broad spectrum of regulatory activities in support of DMID clinical research activities.
Description: This initiative will support a wide range of regulatory activities, including:
- Data and document collection and compilation for regulatory filing for investigational new drug (IND) applications and investigational device exemptions (IDE) with the FDA.
- Technical writing, review, and report preparation.
- Computer information systems for tracking regulatory activities and for inventory purposes.
- General logistical support for regulatory activities, including meeting support.
- Design and conduct of educational activities and tools.
- Expert consultants and auditors.
Phase I Clinical Trial Units for Therapeutics
Request for Proposals
Contact: Chase Lucas
Objective: To establish clinical trial units that will conduct evaluations to determine the safety, pharmacokinetics, and pharmacodynamics of investigational therapeutic products for infectious diseases caused by viral, bacterial, parasitic, and fungal pathogens.
Description: This program provides the necessary capacity to evaluate in Phase I clinical trials the growing pipeline of investigational products arising from the Division's preclinical and early product development programs as well as those arising from other research partners. Candidate therapeutics include new, untested investigational products and novel immunomodulatory agents. Moreover, the program provides dedicated resources necessary to implement early clinical trials in healthy populations in an expeditious and efficient manner. In addition to providing the facilities and resources needed to conduct Phase I studies, the program supports qualified staff with clinical expertise to carry out all aspects of Phase I clinical trials, including subject recruitment; protocol development, implementation, and oversight; clinical specimen storage and tracking; and data management and analysis.